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Comparison of the effect of Aloe Vera and Paradontax herbal toothpastes on plaque, bleeding and mild to moderate gingivitis: a clinical trial study

Protocol summary

Study aim
Comparison of Aloe Vera and Paradontax herbal toothpaste efficacy on the plaque, bleeding and mild to moderate gingivitis in Guilan dental school students in the academic year 99-1400
Design
Randomized, parallel, and double-blind clinical trial. To determine the sample size concerning the repetition of the measurements in 2 groups for each individual, the effect of each individual must be regarded. So the suitable formula with duplicate sizes is used. Considering 4 repitition, a correlation of 0.50, the statistical power of 80%, error level of 0.05, and standard deviation of previous studies based on plaque index equal to 0.55, the minimum sample size equal to 20 for each group. It has been found that considering the probability of specimen shedding in each group, 24 individuals are considered. The trial is in phase 3. ________________________________________
Settings and conduct
Students of Guilan Dental School will be selected by the available sampling method after the initial examination according to the inclusion criteria. They are randomly divided into two groups, and the examiner who measures and records the indicators is generally unaware of the study process.
Participants/Inclusion and exclusion criteria
Patients are selected from non-smoker youth with mild gingivitis, at least 20 teeth and a complete health situation, free of periodontal pockets, clinical attachment loss, systemic problems, use of medications affecting the periodontium. Also, they must not have been received non-surgical and surgical periodontal treatments during the one and three past months.
Intervention groups
Patients are divided into two groups of Aloe Vera and Paradontax toothpaste recipients. Both are given standard health instruction and determined toothpaste at the beginning of the study.
Main outcome variables
Primary outcomes include: Dental plaque index, gingival bleeding index, gingivitis index.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080824001081N10
Registration date: 2020-05-28, 1399/03/08
Registration timing: prospective

Last update: 2020-05-28, 1399/03/08
Update count: 0
Registration date
2020-05-28, 1399/03/08
Registrant information
Name
Golpar Radafshar
Name of organization / entity
Guilan University of Medical Sciences, School of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 0775
Email address
golshad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2020-12-09, 1399/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Aloe Vera and Paradontax herbal toothpastes on plaque, bleeding and mild to moderate gingivitis: a clinical trial study
Public title
Comparison of the effect of two herbal toothpastes on dental plaque control and mild to moderate gingivitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 22 years Agreement upon signing an informed consent Patients with mild chronic gingivitis with MGI score = 1 having at least 20 standing teeth
Exclusion criteria:
Patients with any systemic disease according to patient's history The presence of dental prostheses in the form of bridges The presence of orthodontic appliances The presence of severe crowding Mouth breathing with inadequate upper lip coverage by clinical examination The presence of any periodontal pockets (depth> 3 mm with) Clinical attachmet loss more than 1mm Smoking Use of any antibiotics and medications that have gum issues such as gingival enlargement over the past month. Receive any non-surgical or surgical periodontal treatment during the past three months
Age
From 18 years old to 22 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple block randomization method using excel software. Individuals as units of randomization. The sequence builds as follows: Block identifier, block size, sequence within block, treatment group, intervention code.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, the clinical examiner who evaluates and records the periodontal indices at baseline, 1 and 3 months post intervention is blinded to the case and control groups. Toothpaste tubes are also identified by white coatings to blind the study participants
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Dental Faculty of Guilan University of Medical Sciences, Fuman-Saravan Highway
City
Rasht
Province
Guilan
Postal code
41941-73774
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.GUMS.REC.1399.036

Health conditions studied

1

Description of health condition studied
Chronic plaque-induced gingival inflammation
ICD-10 code
K05.10
ICD-10 code description
Chronic gingivitis, plaque induced

Primary outcomes

1

Description
plaque index
Timepoint
Baseline, one, two and three months post-intervention
Method of measurement
Tureskey-Gilmore –Glilckman modification of the Quigley-Hein Plaque index and Rustogi Modification of the modified Navy Plaque index

2

Description
Gingival inflammation
Timepoint
Baseline, one, two and three months post-intervention
Method of measurement
Modified gingival index

3

Description
Gingival bleeding
Timepoint
Baseline, one, two and three months post-intervention
Method of measurement
Gingival bleeding index, Ainamo & Bay

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First intervention group, Aloe Vera toothpaste recipient: All patients receive Modified Bass toothbrush training and are advised to use as much pea toothpaste as possible. Brush twice daily for 5 minutes each day.
Category
Prevention

2

Description
Intervention group: Second intervention group, Parodontax toothpaste recipient: Similar to the first group, all patients are trained in the method of brushing using the Modified Bass method, and they are advised to use the same amount of toothpaste as the pea seed in each serving. Brush twice daily for 5 minutes each day.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Periodontics, Faculty of Dentistry, Guilan University of Medical Sciences
Full name of responsible person
Athena Khaleghian
Street address
Dental Faculty of Guilan University of Medical Sciences, Fuman-Saravan Highway
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3322 9599
Fax
+98 13 3332 2444
Email
research@gums.ac.ir
Web page address
http://www.gums.ac.ir/research

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Naghipoor
Street address
6th floor, central building of the Gilan University of Medical Sciences, opposite Azodi stadium, Namjoo Street
City
Rasht
Province
Guilan
Postal code
41446-56513
Phone
+98 13 3322 9599
Fax
Email
research@gums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Researchers
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr, Golpar Radafshar
Position
Associate professor of Periodontology, Department of Periodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Faculty of Guilan University of Medical Sciences, Fuman-Saravan Highway
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
golishad@gmail.com
Web page address
http://www.gums.ac.ir/dental

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr, Golpar Radafshar
Position
Associate professor of Periodontology, Department of Periodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Faculty of Guilan University of Medical Sciences, Fuman-Saravan Highway
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
golshad@gums.ac.ir
Web page address
http://www.gums.ac.ir/dental

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Athena Khaleghian
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Gilan University of Medical Sciences, Fuman-Saravan highway
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3348 6406
Email
Sunsetdrive2000@yahoo.com
Web page address
http://www.gums.ac.ir/dental/Default.aspx?tabid=902

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participants do not consent that their data get published.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Since we intend to publish an article based on the present research, the only available data is through the potential article.
When the data will become available and for how long
Within the next 6-8 months the article will get ready for submission and an exact date of publication is not predictable since it depends on the assigned journal policy.
To whom data/document is available
Researchers intend to publish the article in an open access journal so all the stakeholders and interested professionals will be able to access to the content.
Under which criteria data/document could be used
This research will be published in line with the international and national goal for improving dental and periodontal hygiene instruction among young adults.
From where data/document is obtainable
Searching the article key words in any search engine would guide the interested people to the article.
What processes are involved for a request to access data/document
No particular process will not be necessary.
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